UnitedHealthcare ILR Coverage Update

Coverage Criteria — ILRs and Wearable Monitors

Initial ILR Insertion (Medically Necessary)

Covered when ALL of the following are met:

ILR initial insertion criteria: Noninvasive cardiac event recording is contraindicated or yielded non-diagnostic results after at least two weeks of monitoring, and one or more of the listed clinical circumstances are presentat least two weeks noninvasive monitoring

Clinical circumstances include suspected paroxysmal atrial fibrillation after cryptogenic stroke or other systemic thromboembolic event; suspected or known ventricular arrhythmia; high arrhythmia risk due to structural or infiltrative heart disease (e.g., aortic stenosis, hypertrophic cardiomyopathy, cardiac sarcoidosis, congenital heart disease, family history, dilated ischemic or nonischemic cardiomyopathy) or use of medications known to cause malignant arrhythmias; recurrent or unexplained infrequent syncope after modification of potentially causative medications or associated with autonomic dysfunction; or abnormal tests such as electrophysiology study or tilt table testing

Replacement of ILR (Medically Necessary)

Replacement is covered when ALL of the following are met:

ILR replacement criteria: Member continues to meet all initial insertion criteria and the existing device is beyond its useful life, is irreparable, or is no longer operatingdevice beyond useful life or not operating

Replacement requires continued indication as per initial insertion criteria

Guideline-based monitoring indications

Covered/reasonable when meeting guideline-based indications (summarized from multiple society guidelines):

AF after cryptogenic stroke/TIA: Initial cardiac monitoring and, if needed, extended monitoring with an ILR or long-term monitoring is reasonable to improve detection of AF in patients with stroke or TIA of undetermined cause; for acute ischemic stroke/TIA, at least 24 hours then continuous ECG monitoring for 72 hours is recommended, and consider additional long-term noninvasive or insertable monitors in selected patients (elderly, comorbidities, left atrial remodeling, high risk scores)

Sources: ACC/AHA/ACCP/HRS; AHA/ASA; ESC

Unexplained syncope: For patients with infrequent, recurrent unexplained syncope and nondiagnostic initial workup, an ILR is reasonable/indicated; choose monitoring modality and duration based on symptom frequency, with external loop recorder as an initial noninvasive option and ILR if nondiagnostic or symptoms are infrequent (>30 days)

Sources: ACC/AHA/HRS; Shen et al.; Kusumoto et al.

Hypertrophic cardiomyopathy (HCM): 24-48 hour ambulatory ECG is recommended in initial evaluation and periodic follow-up; extended (>24 hours) monitoring or event recording is recommended for palpitations/lightheadedness; consider extended monitoring to screen for AF in high-risk HCM patients and consider periodic screening in others

Cardiac Self-Monitoring Devices (Not Medically Necessary)

Consumer-grade self-monitoring devices: Cardiac self-monitoring devices and software applications commercially available to the public and purchased for home use are considered not medically necessary due to insufficient evidence of efficacy and are considered convenience itemsinsufficient evidence

Examples include ECG-enabled watches/phones and hardware/software required for downloading ECG data to personal devices

Evidence summary for consumer/self-monitoring devices

Coverage stance informed by clinical evidence:

Consumer/mobile ECG technologies: Evidence shows increased arrhythmia detection compared with routine care or short-term Holter in some studies and large observational cohorts, but overall clinical outcome benefit (reduced strokes, mortality, or other patient-centered outcomes) is unclear due to small randomized trials, false positives, limited follow-up, and study limitations; clinical use should include validation and confirmatory diagnostic testing and clinician review

Sources: Hayes evolving review (2021, updated 2023), Koh et al., iHEART, Apple Heart Study

Wearable heart rhythm monitors and cardiac self-monitoring devices that are commercially available to the general public and purchased for home use are considered convenience items and not medically necessary. The policy’s rationale is that these consumer-grade devices and any required hardware or software for downloading ECG data to personal devices have not demonstrated sufficient evidence of safety and efficacy to replace clinically indicated monitoring or confirmatory testing. Examples include ECG-enabled watches or phones and software/hardware used to transfer ECG recordings to personal computers, tablets, or smartphones.

There are no explicit coverage exclusions listed beyond the policy statement that consumer-grade devices purchased for home use are considered convenience items and not medically necessary. Evidence reviews and individual studies, however, highlight limitations — including low return rates of confirmatory ECG patches, loss to follow-up, younger study populations, lack of comparison groups, small sample sizes, and short follow-up — creating uncertainty about clinical benefit. These limitations may inform noncoverage decisions for standalone use of mobile medical applications (MMAs) or wearables without clinician-confirmed diagnostic follow-up.

FDA classification, clearance, or approval of a device is provided for informational purposes only. FDA approval alone is not a basis for coverage, and device product codes or regulatory status should not be interpreted as a guarantee of medical necessity or reimbursement.

The policy considers consumer cardiac self-monitoring devices and the associated hardware/software for home use to be not medically necessary because available evidence does not establish that their use improves patient health outcomes compared with clinically directed monitoring strategies. While some studies report higher arrhythmia detection rates with consumer technologies, the body of evidence is limited by study size, follow-up duration, and methodological issues; therefore these devices are treated as convenience items and are not a substitute for clinician-directed diagnostic evaluation.

A Hayes evidence review (2021, updated 2023) concluded there was no clear or consistent support for the clinical utility of mobile medical applications for arrhythmia detection with respect to improved clinical outcomes. Although some included studies reported increased episode detection compared with routine care or short-term Holter monitoring, the review found the evidence insufficient to demonstrate benefits such as reduced stroke or mortality, and the update in 2023 did not change that conclusion.

Coding — Procedure and Device Codes

Implantable Loop Recorder / Monitoring CPT CodesCPT

0650T	Programming device evaluation (remote) of subcutaneous cardiac rhythm monitor system, with iterative adjustment of the implantable device to test the function of the device and select optimal permanently programmed values with analysis, review and report by a physician or other qualified health care professional.
33285	Insertion, subcutaneous cardiac rhythm monitor, including programming.
33286	Removal, subcutaneous cardiac rhythm monitor.
93285	Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; subcutaneous cardiac rhythm monitor system.
93291	Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; subcutaneous cardiac rhythm monitor system, including heart rhythm derived data analysis.
93297	Interrogation device evaluation(s), (remote) up to 30 days; implantable cardiovascular physiologic monitor system, including analysis of 1 or more recorded physiologic cardiovascular data elements from all internal and external sensors, analysis, review(s) and report(s) by a physician or other qualified health care professional.
93298	Interrogation device evaluation(s), (remote) up to 30 days; subcutaneous cardiac rhythm monitor system, including analysis of recorded heart rhythm data, analysis, review(s) and report(s) by a physician or other qualified health care professional.

Cardiac Self-Monitoring Device CPT CodesCPT

0902T	QTc interval derived by augmentative algorithmic analysis of input from an external, patient-activated mobile ECG device
93799	Unlisted cardiovascular service or procedure

HCPCS CodesHCPCS

E0616	Implantable cardiac event recorder with memory, activator, and programmer.
E1399	Durable medical equipment, miscellaneous

FDA product codes referencedmixed

DSI	FDA product code referenced for ambulatory ECG devices and cardiac telemetry/ILR
MXD	FDA product code referenced for ambulatory ECG devices and cardiac telemetry/ILR
DXH	FDA product code referenced for ambulatory ECG devices and cardiac telemetry/ILR
DPS	FDA product code for cardiac self-monitoring devices
QDA	FDA product code for cardiac self-monitoring devices

AF episode duration for detection/action in trials

Primary trial threshold30 seconds (STROKE-AF and similar trials used AF episodes >30 seconds for detection endpoints)

Alternate anticoagulation threshold6 minutes (Svendsen et al. RCT recommended anticoagulation if AF episodes lasted ≥6 minutes)

Follow-up duration contextSTROKE-AF monitored participants through 12 months (with continued follow-up to 36 months or battery end) for AF >30 seconds

Holter monitor duration

Typical wear time24–48 hours (Holter monitors are typically worn for this duration)

Provider Actions — Authorization, Documentation, and Workflow

Prior Authorization

Prior Authorization May Be Required

Prior authorization may be implied for Implantable Loop Recorder (ILR) placement when prior noninvasive monitoring is nondiagnostic and ILR is being requested to evaluate infrequent or unexplained syncope or to detect occult atrial fibrillation after stroke. Providers should verify and obtain any required authorization per the member's benefit plan before implanting an ILR.

ILR placement often follows nondiagnostic short-term or extended external monitoring (Holter, patch, MCOT) per guideline-recommended workflows.
Check member-specific federal, state, or contractual benefit requirements; plan terms may require prior authorization or have different coverage rules.

Note

Use Policy with Benefit Plan Requirements

Interpret and apply this policy in the context of the member’s federal, state, or contractual benefit plan. In the event of a conflict between this policy and a member’s benefit contract or applicable law, the contract or law governs. Providers should confirm coverage rules, prior-authorization requirements, and any plan-specific documentation or coding expectations before submitting requests.

Definitions

Cardiac Self-Monitoring Devices

DefinitionConsumer-grade, connected electronic devices and/or software applications that members can use without a physician's prescription to collect physiologic data (ECG, heart rate, etc.)

Typical distribution/useCommercially available to the general public and purchased for home use; data downloaded to personal devices (smartphone, smartwatch, tablet)

Regulatory noteFDA classifies mobile cardiac self-monitoring devices as Class II (informational only; FDA status not a basis for coverage)

Implantable Loop Recorder

DefinitionA subcutaneously placed device that continuously records the heart's electrical activity and can transmit data to a clinician to detect infrequent palpitations or causes of syncope

Clinical purpose

Background and Evidence

Cardiac arrhythmias may be symptomatic or asymptomatic; choice of ambulatory ECG monitoring depends on symptom frequency and the clinical question. Short-term monitors (for example, Holter or patch monitors) are commonly used for frequent or daily symptoms, whereas an insertable/implantable loop recorder (ILR) provides prolonged continuous monitoring and is used when noninvasive monitoring is nondiagnostic or when events are infrequent (for example, evaluation after cryptogenic stroke or unexplained syncope). ILRs enable long-term rhythm surveillance when initial ambulatory testing has not established a diagnosis.

Revision History

2025-12-01policy_revisionLatest

Added requirement that the patient medical record must contain legible documentation fully supporting medical necessity (including relevant history, physical exam, and pertinent diagnostic test results) and be maintained and made available upon request; removed reference link to the 'Medical Records Documentation Used for Reviews' guidelines.

OpenPayer

Implantable Loop Recorders and Wearable Heart Rhythm Monitors (for Nebraska Only)